TG United Recalls Underdosed AMBI Cold and Flu Syrup
TG United, Inc. is recalling 348 bottles of AMBI cold and flu syrup due to CGMP deviations resulting in underdosed products.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe. While no injuries are reported, the underdosing of a pharmaceutical product represents a significant risk of harm, aligning with the Severe criteria for significant injury reports or structural defects in the rubric's context of Class II severity.
Plain-English summary
TG United, Inc. is recalling 348 16-ounce bottles of AMBI 3BRM/30DM/50PSE, an over-the-counter antihistamine, cough suppressant, and nasal decongestant in Berry Vanilla flavor. The product is manufactured for AMBI Pharmaceuticals and carries NDC 66870-0229-16.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the affected products are underdosed or have an incorrect dosage regime. The affected lot is # 12HQ004 with an expiration date of 07/14.
The recalled product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas. Consumers who possess this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16
- Manufacturer
- TG United, Inc.
- Category
- Drug — OTC Cold and Flu
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 12HQ004
- Exp. 07/14.
Distribution
Part of a larger recall action
This product is one of 44 recalled by TG United, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 44 products in this recall →Related recalls
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